Untitled Untitled

Untitled Jan 17, 2019

Human Subjects Research Untitled
Principles & Declarations
Forms & Certification
Key Agencies
Role of the
Principal Investigators
& Researchers


IACUC, BioSafety
& Radiation Safety


Related Sites:

Health Resources
Health Topics
AIDS Primer
Cancer Resources
Heart Diseases
& Stroke

Medical Centers

Nutrition & Metabolism

Science & Technology

The Scientist

Reference Desk

Treasures of the Internet

Untitled Untitled Untitled
Untitled Institutional Review Board (IRB)
    Visit also the Bioethics website and use the health and science-focused Untitled Search engines and directories section to find additional information about the topics listed below.
  • Title 45 Public Welfare -- Subtitle A -- DHHS -- Part 46 -- Protection of Human Subjects29
    • Text PDF 45.46.101 To what does this policy apply? 29
    • Text PDF 45.46.102 Definitions. 29
    • Text PDF 45.46.103 Assuring compliance with this policy--research conducted or supported by any Federal Department or Agency.29
    • Text PDF 45.46.107 IRB membership.29
    • Text PDF 45.46.108 IRB functions and operations.29
    • Text PDF 45.46.109 IRB review of research.29
    • Text PDF 45.46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.29
    • Text PDF 45.46.111 Criteria for IRB approval of research.29
    • Text PDF 45.46.112 Review by institution.29
    • Text PDF 45.46.113 Suspension or termination of IRB approval of research.29
    • Text PDF 45.46.114 Cooperative research.29
    • Text PDF 45.46.115 IRB records. 29
    • Text PDF 45.46.116 General requirements for informed consent. 29
    • Text PDF 45.46.117 Documentation of informed consent.29
    • Text PDF 45.46.118 Applications and proposals lacking definite plans for involvement of human subjects.29
    • Text PDF 45.46.119 Research undertaken without the intention of involving human subjects.29
    • Text PDF 45.46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency.29
    • Text PDF 45.46.122 Use of Federal funds.29
    • Text PDF 45.46.123 Early termination of research support: Evaluation of applications and proposals.29
    • Text PDF 45.46.124 Conditions.29
    • Text PDF 45.46.201 Applicability. 29
    • Text PDF 45.46.202 Purpose. 29
    • Text PDF 45.46.203 Definitions. 29
    • Text PDF 45.46.204 Ethical Advisory Boards. 29
    • Text PDF 45.46.205 Additional duties of the Institutional Review Boards in connection with activities involving fetuses, pregnant women, or human in vitro fertilization. 29
    • Text PDF 45.46.206 General limitations. 29
    • Text PDF 45.46.207 Activities directed toward pregnant women as subjects. 29
    • Text PDF 45.46.208 Activities directed toward fetuses in utero as subjects. 29
    • Text PDF 45.46.209 Activities directed toward fetuses ex utero, including nonviable fetuses, as subjects. 29
    • Text PDF 45.46.210 Activities involving the dead fetus, fetal material, or the placenta. 29
    • Text PDF 45.46.211 Modification or waiver of specific requirements. 29
    • Text PDF 45.46.301 Applicability. 29
    • Text PDF 45.46.302 Purpose. 29
    • Text PDF 45.46.303 Definitions. 29
    • Text PDF 45.46.304 Composition of Institutional Review Boards where prisoners are involved.29
    • Text PDF 45.46.305 Additional duties of the Institutional Review Boards where prisoners are involved.29
    • Text PDF 45.46.306 Permitted research involving prisoners.29
    • Text PDF 45.46.401 To what do these regulations apply?29
    • Text PDF 45.46.402 Definitions.29
    • Text PDF 45.46.403 IRB duties.29
    • Text PDF 45.46.404 Research not involving greater than minimal risk.29
    • Text PDF 45.46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.29
    • Text PDF 45.46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.29
    • Text PDF 45.46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.29
    • Text PDF 45.46.408 Requirements for permission by parents or guardians and for assent by children. 29
    • Text PDF 45.46.409 Wards. 29
  • see also Institutional Review Boards
  • Visit the Untitled Federal Register and use the search section to obtain recent updates of 21.56 & 45.46.

Notes and Footnotes:
    Untitled Click on Untitled Literature Sources to access the source of the information database, specified as superscript after each topic link.


Untitled First Written: 19990118 Latest Update: 20060328
    [an error occurred while processing this directive]